1. Field of the Invention
The present invention relates generally to a blood-collection position indicator serving as a mark for allowing a blood collecting instrument or the like to be guided easily in blood collection from a finger or the like.
2. Related Background Art
Currently, as a method of measuring a blood glucose level (a glucose concentration) through blood collection at home by diabetics without requiring them to visit a medical institution, for instance, the following method has been practiced widely, in which a lancet and a simplified glucose measuring instrument are used.
The above-mentioned lancet is a disposable needle or cutting tool used for puncturing the skin of a patient, which is set in its own ejection device called a xe2x80x9clancet devicexe2x80x9d and then is used. Further, for example, as shown in FIG. 23, a simplified glucose measuring instrument 6 includes a disposable strip 61 and a meter 62 used exclusively for measuring a glucose content with the disposable strip 61 being set therein. The disposable strip 61 has a specimen supply section and a reagent section containing glucose oxidase or the like that reacts specifically with glucose contained in a specimen. Generally, the strip 61 has a capillary structure so as to allow a supplied specimen to be transported.
Using the lancet and the measuring instrument, for instance, glucose can be measured as follows. Initially, the lancet is set inside a lancet device, and a tip of the lancet device is brought close to a skin surface. Then, the lancet thus set is ejected to puncture the skin and blood is squeezed out from the punctured site to form a blood xe2x80x9cpoolxe2x80x9d. Then, when the tip of the strip 61 of the measuring instrument 6 is brought into contact with the blood in the punctured site, the strip 61 absorbs the blood by a capillary phenomenon and transports it to the reagent section. In the reagent section, glucose in the blood and the reagent start to react with each other. After the glucose and the reagent are allowed to react with each other for a certain period, the meter 62 detects the reaction product of them and converts it into a glucose concentration, which then is displayed on a monitor.
However, for diabetics having total blindness or weak eyesight because of complication of diabetes, patients who cannot carry out fine manual operations, or the like, for instance, it is difficult to bring the tip of the strip 61 into contact with the blood in the punctured site punctured with a lancet or to carry out the aforementioned series of operations alone.
In order to solve such problems, for example, JP 10-295675 A discloses a finger band for blood collection provided with a blood collection hole and a retaining part for holding a finger. When this finger band is used, the blood collection hole functions as a guide for a blood-collecting needle. Therefore, it is easy to bring the blood-collecting needle into contact with a target position on the skin using the sense of touch. In addition, blood can be dropped from the blood collection hole directly on a diagnostic device.
However, such a finger band has a difficulty in being attached to or detached from the punctured site. It has been required to puncture the skin more easily and to provide blood for a measuring device such as the simplified glucose measuring instrument easily.
The present invention at least in its preferred embodiments is intended to provide a blood-collection position indicator serving as a mark for a punctured site on the skin and allowing blood to be collected from the punctured site easily.
In order to achieve the above-mentioned object, the present inventors found the following two blood-collection position indicators.
A first blood-collection position indicator of the present invention includes an adhesive portion to be stuck to skin, an attachment part, into which a tip of a lancet device including a lancet is attached, and a blood collection hole, wherein the blood-collection position indicator is attached to the tip of the lancet device in a state where the lancet is arranged to pass through the blood collection hole before the lancet device is used, and wherein the adhesive strength of the adhesive portion to the skin is stronger than the attachment strength of the attachment part to the tip of the lancet device, whereby in use, the blood-collection position indicator adheres to and remains on the skin after the lancet device is used.
When using such a first blood-collection position indicator, a patient can recognize a punctured site on the skin through the blood-collection position indicator by the sense of touch without relying on the visual sense. The patient can bring the tip of a strip in the aforementioned measuring instrument into contact with blood in the blood collection hole of the blood-collection position indicator, thus collecting blood easily. In addition, as described above, it is not necessary to position a member having a guide function on a finger or the like before the blood collection and to bring a lancet close to the finger after recognizing the member. Therefore, the operation can be carried out more easily and quickly. Furthermore, since the blood-collection position indicator can be fixed to the skin without using such a band as described above, the blood collection site is not limited. Consequently, when the first blood-collection position indicator of the present invention is used, for example, even patients with visual handicap or the like can collect blood easily, and it also is possible to collect blood easily from a site such as an ear or the like, which is difficult to be recognized by the patient himself. Thus, the first blood-collection position indicator is useful for blood collection for diagnosis in clinical medicine and particularly for self-diagnosis at home.
The following examples are preferable as the configuration of the attachment part.
For instance, in the case of a blood-collection position indicator in which the blood collection hole serves as the attachment part, the tip of the lancet device may be inserted into the blood collection hole, thus attaching the blood-collection position indicator to the tip of the lancet device. In the case of a blood-collection position indicator having a protruding portion as the attachment part, the protruding portion may be inserted into a hole of the tip of the lancet device, thus attaching the blood-collection position indicator to the tip of the lancet device. In addition, in the case of a blood-collection position indicator having a cylindrical shape with a bottom, it is preferable that its inner space (hereinafter also referred to as a xe2x80x9cconcave portionxe2x80x9d) serves as the attachment part, the tip of a lancet device is inserted into the concave portion, thus attaching the blood-collection position indicator to the tip of the lancet device, the bottom is provided with a through hole serving as the blood collection hole, and an outer bottom face of the bottom is provided with the adhesive portion. In the specification, the xe2x80x9ccylindrical shapexe2x80x9d of the cylindrical shape with a bottom is not limited to one with a circular planar shape and may be one whose planar shape is rectangular, polygonal, or the like.
Preferably, an inner circumferential face of a cylindrical portion with the cylindrical shape with a bottom has at least one groove along a depth direction, a part of a peripheral surface of the tip of the lancet device is brought into contact with and is pressed against a portion except for the groove of the inner circumferential face, thus attaching the blood-collection position indicator to the tip of the lancet device in a pressure contact state, and the part being in contact with and being pressed against the portion is movable to be positioned in the groove, thus releasing the pressure contact state.
Preferably, the tip of the lancet device has a rectangular shape. It is preferable that the blood-collection position indicator has the following configuration. For example, the inner circumferential face of the cylindrical portion having the cylindrical shape with a bottom is provided with at least one groove along the depth direction, corners of the rectangular tip of the lancet device are brought into contact with and are pressed against the portion except for the groove of the inner circumferential face, thus attaching the blood-collection position indicator to the tip of the lancet device in a pressure contact state, and the corners of the rectangular tip are moved to be positioned in the groove, thus releasing the pressure contact state. Alternatively, according to another preferred embodiment, the tip of the lancet device has an elliptical shape. It is preferable that the blood-collection position indicator has the following configuration. For example, the inner circumferential face of the cylindrical portion having the cylindrical shape with a bottom is provided with at least one groove along the depth direction, side ends, in a major axis direction, of the elliptical tip of the lancet device are brought into contact with and are pressed against the portion except for the groove of the inner circumferential face, thus attaching the blood-collection position indicator to the tip of the lancet device in a pressure contact state, and the side ends being in contact with and being pressed against the portion are moved to be positioned in the groove, thus releasing the pressure contact state.
Preferably, the blood collection hole includes a portion with a tapered shape expanding in a direction away from the skin, in use. Thus, in the case of a blood-collection position indicator having a cylindrical shape with a bottom, it is preferable that the through hole includes a portion with a tapered shape expanding toward an inner portion of the cylindrical portion. This allows blood to flow easily into the concave portion of the cylindrical shape with a bottom.
As described above, the first blood-collection position indicator may be attached to the tip of the lancet device to form one body through the above-mentioned insertion. A surface to be brought into contact with the tip of the lancet device may, for example, be provided with an adhesive portion serving as the attachment part, and the blood-collection position indicator may be attached to the tip of the lancet device by adhesion through the adhesive portion.
Preferably, an annular protruding portion surrounding the blood collection hole is provided on a surface to be positioned to face the skin. The formation of such an annular protruding portion prevents blood from flowing through a gap between the skin and the blood-collection position indicator by a capillary phenomenon. This also prevents blood to be collected from leaking out from the blood-collection position indicator. For instance, even when a double-sided tape or the like is used for the adhesive portion to allow the blood-collection position indicator to adhere to the skin, problems such that its adhesive strength is decreased due to the penetration of blood into the double-sided tape or the like are not caused in a considerable manner.
Preferably, the blood collection hole has a quantitative function. It has been difficult for a patient to judge whether the amount of collected blood is a sufficient amount required for measurement when the patient collects blood by himself. According to this, however, a sufficient or certain amount of blood can be collected easily. The quantitative function can be obtained, for example, by setting of the internal volume of the blood collection hole according to the amount of blood required for the measurement or the like. However, it is preferred to set the internal volume of the blood collection hole with consideration to factors such as surface tension and viscosity of blood.
Preferably, the first blood-collection position indicator further includes a cover layer on a surface of the adhesive portion, to be stuck to the skin, wherein the cover layer is removable before the adhesive portion is stuck to the skin. Such a cover layer can prevent the deterioration in adhesiveness.
As described above, it is preferable that the first blood-collection position indicator of the present invention has a cylindrical shape with a bottom. More preferably, the first blood-collection position indicator has the following configuration. A through hole serving as a blood collection hole is formed in the bottom of the cylindrical body with a bottom. An adhesive portion is provided on the outer bottom surface of the bottom. An annular protruding portion surrounding the through hole may be provided on the outer bottom surface. The through hole may include a portion with a tapered shape expanding toward the inner portion of the cylindrical body. The inner circumferential face of the cylindrical portion having the cylindrical shape with a bottom may be provided with at least one groove. A part of the peripheral surface of the tip of a lancet device may be brought into contact with and pressed against a portion except for the groove of the inner circumferential face, thus attaching the first blood-collection position indicator to the tip of the lancet device in a pressure contact state, and the part being in contact with and being pressed against the portion may be moved to be positioned in the groove, thus releasing the pressure contact state.
A second blood-collection position indicator of the present invention includes a pair of clip members, wherein the pair of clip members are in contact with each other at a supporting point and include clip parts for holding skin, which are formed on one side with respect to the supporting point as the center, and grip parts formed on the other side, respectively, the clip parts are urged to be in a closed state, at least one of the clip parts has an attachment part to be attached to a tip of a lancet device including a lancet, and the attachment part is provided with a blood collection hole, through which the lancet can pass.
In such a second blood-collection position indicator of the present invention, as described above, since the clip parts are urged to be in a closed state (i.e. with the clip parts being pressed against each other when the clip is not in use), it is only necessary to hold a blood collection site such as a fingertip or the like with the clip parts using a force applied to the clip parts. Consequently, a patient can attach or detach the blood-collection position indicator easily. When an indicator is fixed to the blood collection site and, for example, an adhesive tape or the like is used, there is a fear of insufficient fixation due to the decrease or deterioration in adhesiveness or the like or a problem of cost increase for reusing it. However, since the second blood-collection position indicator of the present invention is fixed to the blood collection site sufficiently by the force applied to the clip parts, for example, even when the tip of a lancet device is attached to the blood-collection position indicator or skin is punctured by the lancet, it is avoided that the blood-collection position indicator is displaced or detached from the blood collection site due to such operations. When being reused, the second blood-collection position indicator of the present invention is required only to be washed, pasteurized, or the like, thus allowing cost reduction. In addition, it is easy for a patient to recognize the puncture site on the skin through the blood-collection position indicator using the sense of touch without relying on the visual sense or to collect blood by bringing the tip of a strip of the above-mentioned measuring instrument into contact with the blood pooled in the blood collection hole. Therefore, in the case of using the second blood-collection position indicator of the present invention, for example, it can be fixed to the blood collection site sufficiently and it is possible even for a patient with visual handicap or the like to collect blood easily. Thus, the second blood-collection position indicator of the present invention is useful for blood collection for diagnosis in clinical medicine, particularly for self-diagnosis at home.
Preferably, at least one of the clip parts is provided with a concave portion having a bottom, the bottom of the concave portion is provided with a through hole serving as the blood collection hole, and the tip of the lancet device is attached to an inner space of the concave portion. In such a blood-collection position indicator, for example, the tip of the lancet device may be inserted into the inner space, thus attaching the blood-collection position indicator to the tip of the lancet device, and then puncture and blood collection may be operated through the through hole. In this way, by providing the concave portion, the blood collection site is recognized easily by a patient and, for example, the tip of the lancet device or the tip of the strip of the aforementioned measuring instrument is brought into contact with blood in the blood-collection position indicator easily.
Preferably, the clip part having the blood collection hole is provided with an annular protruding portion surrounding the blood collection hole on a surface, of the clip part, to be brought into contact with the skin. The formation of such an annular protruding portion on the surface to be brought into contact with the skin can prevent blood from flowing through a gap between the skin and the blood-collection position indicator by a capillary phenomenon, thus allowing blood collection without wasting the blood. In addition, the annular protruding portion presses the skin to cause blood congestion, and therefore a sufficient amount of blood can be obtained easily.
Preferably, the blood collection hole has a quantitative function. It has been difficult for a patient to judge whether the amount of collected blood is a sufficient amount required for measurement when the patient collects blood by himself According to this, however, a sufficient or certain amount of blood can be collected easily. The quantitative function can be obtained, for example, by setting of the internal volume of the blood collection hole according to the amount of blood required for the measurement or the like. However, it is preferred to set the internal volume of the blood collection hole with consideration to factors such as surface tension and viscosity of blood.
Preferably, the attachment part can be detached. According to such a configuration, for example, when the second blood-collection position indicator is reused, only this attachment part may be washed, pasteurized, or the like, or alternatively, when the second blood-collection position indicator is a disposable type, only the attachment part may be replaced, thus achieving cost reduction. Therefore, the second blood-collection position indicator is useful particularly for blood collection at home or the like.
In the second blood-collection position indicator of the present invention, the following examples are preferable as the configuration of the attachment part and the attachment state between the tip of the lancet device and the attachment part.
Preferably, the concave portion has an inner circumferential face provided with at least one groove along a depth direction, a part of the peripheral surface of the tip of the lancet device is brought into contact with and is pressed against a portion except for the groove of the inner circumferential face, thus attaching the attachment part to the tip of the lancet device in a pressure contact state, and the part being in contact with and being pressed against the portion is movable to be positioned in the groove, thus releasing the pressure contact state.
Preferably, the tip of the lancet device has a rectangular shape and corners of the tip are brought into contact with and are pressed against the portion except for the groove of the inner circumferential face of the concave portion, thus attaching the attachment part to the tip of the lancet device in a pressure contact state, and the corners are moved to be positioned in the groove, thus releasing the pressure contact state. Alternatively, according to another embodiment, the tip of the lancet device has an elliptical shape and side ends of the tip in a major axis direction are brought into contact with and are pressed against the portion except for the groove of the inner circumferential face of the concave portion, thus attaching the attachment part to the tip of the lancet device in a pressure contact state, and the side ends being in contact with and being pressed against the portion are moved to be positioned in the groove, thus releasing the pressure contact state.
Preferably, the blood collection hole includes a portion with a tapered shape expanding in a direction away from the skin, in use. This allows blood to flow easily into the inner space of the concave portion.